Regulatory Perspectives on Pharmacy Error Prevention

1. Regulatory Perspectives on Pharmacy Error Prevention David B. Brushwood, R.Ph., J.D. Professor of Pharmaceutical Outcomes & Policy The University of Florida

2. The Problem Of Pharmacy Error • Mechanical Error • Wrong Drug • Wrong Strength • Wrong Directions • Wrong Patient • Judgmental Error • Inaccurate Counseling • Inaccurate DUR • Failure to Counsel • Failure to Conduct DUR • Individual Causes • Lack of Knowledge • Lack of Skill • Lack of Care • Personal Distractions • System Causes • Workflow • Communication • Staffing • Patient Expectations

3. Who Says There Is A Problem? • Criminal Courts • UK Pharmacist Elizabeth Lee. • US Pharmacist Eric Cropp. • http://media.cop.ufl.edu/camtasia/ms/error/video.html • Possible Solution: • Decriminalize “one off” error. • Forgive and Forget. • Licensing Agencies • Shinn Case • http://media.cop.ufl.edu/videos/pha6277/abc.html • Possible Solution • Blame and Shame. • Blame and Train Alternative: Mandatory Continuous Quality Improvement

4. Studies Of Error In Medicine • “Forgive and Remember” • Charles Bosk • “That humans make 0.1 percent errors on prescriptions may be forgivable; that hospitals don’t take obvious actions to protect themselves and patients, well within state-of-the-art, is not.” • Michael Millenson • “Almost all accidents result from human error, it is now recognized that these errors are usually induced by faulty systems that ‘set people up’ to fail. The great majority of effort in improving safety should focus on safe systems, and the health care organization itself should be held responsible for safety.” • The IOM Report

5. The QRE: Clarifying The Use of Language • Error (Backward Looking; Blame-Laying) • Incident (Patient Received Medication) • Near Miss—Near Hit (An Almost Error) • Sentinel Event (Screams Out Danger) • Quality-Related Event (QRE) • Incidents • Near Hits • Sentinel Events • Positive QREs

6. The Quality Team Leader • Does not have all of the answers, but does know how to ask the right questions. • This person is responsible for • Initial training, • Implementation of the program, • Continuation of the program, and • Conduct of Quality Consults. • Not a “spy” for management. This activity is separate from performance evaluation.

7. Steps in Order Processing • Receiving the Order • Data Entry • Utilization Review • Prescription Assembly • Pharmacist Final Check (The Red Line) • Special Care • Delivery to Patient • Follow-up With Patient

8. Receiving The Order • Identify person presenting Rx/Request. • Relax and negotiate realistic pickup time. (Waiter/Later?) Sign re time expectation. • Confirm information in new Rx, refill. • Evaluate Rx/Request. • Confirming patient profile is up-to-date. • Update insurance information. • Original order notes. • Segregate one patient’s order from others.

9. Data Entry • Interpretation of information in Rx/Refill. • Confirming correct patient, prescriber, Rx info. • Check inventory on drug prescribed. • Confirm completeness of patient info—see receiving Rx. • Review previous Rx for changes/confirmation. • Check notes. • Calculate days supply; quantity. • Half minute review.

10. Utilization Review Check if patient is still using cancelled drugs. Notes on old/new Rxs with cross references; same or not same. (SAB) (NEW) Ask patient if patient info can resolve. Hard edits; Pharmacist ONLY to proceed. Soft edits; Info for final check.

11. Prescription Assembly • Review hard copy of Rx. • Identify needed products. • Retrieve needed products from stock. • DIN check & note. • Expiration date check & note. • Appropriate vial. • Storage. • Place appropriate product and quantity in container. Note quantity. • Affix label & auxiliary labels. • Confirm patient-directed information, and special notes (1 of 3, 2 of 3, etc.) • Place all prescriptions for one pt together. • Document ID of preparer.

12. Pharmacist Final Check • Reconcile stock bottle with printed information. • Visualize contents of container. • Hard copy Rx matches computer printed info. • Quantity & refills are correct. • Review DURs; review indication, dose, appropriateness, use patient profile if necessary. • Identify checker. • Make sure documentation has been done. • Place in packaging for patient. • Note if patient needs counseling. • Half minute review. • Place across red line.

13. Special Care Insurance issues. Prescriber issues. Patient issues.

14. Delivery to the Patient Patient ID: Verify Address and/or Phone Number. Show and Tell: Name of drug, directions, refills, told to patient. Maintain patient privacy. Inform of change in Rx; drug. If not delivered in person, confirm receipt.

15. Follow-up With Patient • Check adherence and outcomes. • If delivered other than through personal delivery, provide necessary information.

16. What Does CQI Look Like? • Define the process through which prescriptions are filled. • Make a record of quality related events. • Discuss how systems can be used to prevent similar events in the future.

17. The Pharmacy System and CQI RPh. & P.T. dispense according to established Procedures (Stations??) Quality related event occurs Incident Reports and/or in-store documentation CQI Consultant Reviews CQI Consult held CQI Consultant Reviews Management Kept Informed of Progress Report to Users Data, Analysis Report to Central Data Processing Agency

18. Gathering The Troops • Everyone must participate: Pharmacists, techs, clerks. • There are no stupid questions or suggestions. • Blaming others is forbidden.

19. Setting The Tone • This is a professional meeting to improve outcomes for patients. • The focus is on the future, not the past. • Everything said is held in confidence. • My job is to help you not punish you.

20. Promoting an Orderly Discussion • Reviewing The Facts • Facts about events • Facts about environment • Addressing The Issues • Staffing issues • Workflow issues • Communication Issues • Reviewing Policies • Problem Solving • Problem identification • Problem resolution • Open time for any comment • Encouraging follow through • Follow policies • Remember the team

21. Reviewing Facts About Events • Was the prescription telephoned to the pharmacy, or was it transmitted in writing (paper, fax, or computer)? • Was the prescription a new prescription or a refill prescription? • Was the prescription prepared for a person who chose to wait for it, or was it prepared for the “will call” or delivery area? • Was the prescription dispensed to the patient or to another person acting for the patient? • Was the pharmacist a fill-in pharmacist?

22. Facts About Environment How many prescriptions were filled on the day the incident occurred? How many pharmacists/techs/clerks were working on that day? It is documented that DUR was done (if needed) with the prescription? Is it documented that the patient was offered (or received) counseling? Was there anything “special” about the day?

23. Issues: Staffing Are the supportive staff hours scheduled properly to efficiently handle peaks in prescription volume? Do the pharmacists’ schedules provide for sufficient overlap on peak volume days? Are all personnel properly trained, especially with regard to prescription error prevention procedures?

24. Issues: Workflow Are look alike and sound alike drugs separated in their physical location on shelves to reduce confusion? Is the primary work area/counter organized for accuracy; is it neat and clean? Are baskets used to separate waiting and will call prescriptions?

25. Issues: Communication Are personnel repeating the patient’s name and the name of the physician to the person picking up the prescription? Are pharmacists evaluating all DUR computer prompts before a tech fills a prescription? Are procedures implemented to assure that all medications going into a bag are for that patient?

26. Reviewing Policies Are drug code checks used in filling prescriptions and automatic counting devices? Are telephone refill orders cross checked by obtaining the patient’s name, Rx number, and the name of the medication? Is partner check being used at the end of each day?

27. Toward Solutions How will we know that the problem has been solved? What are the possible solutions to the problem? Of the suggested solutions, which is the best and why?

28. Open Time For Any Comment • Talk with me about whether policies are working. • Talk with me about whether policies are being followed. • Talk with me about the CQI system. • Talk with me about this CQI consult meeting.

29. Pharmacist Only Questions • Why does my medication look different this time? • Why are the directions different from those my doctor told me? • You don’t seem to have spelled my (or my doctor’s) name correctly? • If I’m allergic to aspirin can I take this?

30. Handling a Failure of Quality • First Duty--Practice Good Pharmacy Care for the patient!!!!!! • Attitude, Attitude, Attitude! • Investigate all complaints in a caring manner. • Choose the right language • Write notes carefully • Just the facts. • No scapegoating. • The First Response • Whom to Involve • Pharmacist Responsibility • Where to go • Quiet Place-Confidentiality • Careful Listening • What to Say • “I can see you are upset” • “Thank you for bringing this to our attention” • NOT “We sure got sloppy, what a terrible error.” • The “Safe” Apology • Objective Description • We will learn from this.

31. Time for Questions/Comments